Trial of a facilitated home-based rehabilitation intervention in patients with heart failure
| ISRCTN | ISRCTN47894539 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47894539 |
| EudraCT/CTIS number | Nil Known |
| IRAS number | 298247 |
| Secondary identifying numbers | IRAS 298247, GN19CA434, NIHR130487 |
- Submission date
- 21/07/2021
- Registration date
- 26/07/2021
- Last edited
- 04/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Cardiac rehabilitation (CR) is a highly effective and cost-effective treatment for people with heart failure and is the recommended NHS treatment. It improves quality of life and may reduce risk of a hospital admission. However, at present less than one in 20 people in the UK discharged from hospital with diagnosis of heart failure participate in CR. A key reason for this is that people with heart failure find it difficult to get to hospital, and some dislike group formats. With the COVID-19 pandemic, the barrier to accessing hospital based cardiac rehabilitation programmes has become much greater.
Between 2012-18, the trial team co-developed and tested (with people with heart failure, clinicians, and National Health Service (NHS) managers) a home-based CR programme called ‘Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF)’. Through a clinical trial, they were able to confirm that participation in REACH-HF improves quality of life of people with heart failure with reduced ejection fraction (‘HFrEF’) and that it is affordable for the NHS. They now wish to carry out a study to assess that REACH-HF also works for people with heart failure with preserved ejection fraction (‘HFpEF’).
Who can participate?
Adults aged 18 years or over with HFpEF and their caregivers.
What does the study involve?
Participants who consent to take part will be involved with the study for about twelve months. They will firstly be invited by their local cardiology/heart failure research team to take part in an initial assessment to check that they are suitable to participate in the study and, if so, to complete some questionnaires. If this is a face-to-face meeting, they will also be asked to undertake a walking test and provide a sample of blood. Once the initial assessment is completed, they will then be allocated at random (like tossing a coin) to either the REACH-HF programme plus usual care or usual care only.
For participants assigned to the REACH-HF programme plus usual care group:
They will be contacted by one of the clinical team (usually a CR nurse, HF specialist nurse, physiotherapist) to set up a phone call, online appointment, or home visit (if available) to start participants on the 12-week REACH-HF programme.
The facilitator will help participants to: develop skills for managing heart failure; make plans about how to improve their current situation; monitor their progress over time, and adapt their heart failure management strategies if necessary. More details are available on the REACH-HF website (http://sites.exeter.ac.uk/reach-hf/).
A small group of participants and their caregivers who participate in the REACH-HF programme will be asked to take part in an interview at 4 and 12 months to talk about their experience in receiving the intervention and ways in which it can be improved.
For participants assigned to the usual care group:
They will continue to receive usual care for their heart failure as per their local and national guidelines.
All participants will be asked to repeat the walking test, questionnaires and provide a blood sample at the 4 and 12 months visits.
As part of the study, participants will be asked to wear an activity monitor. This is a wrist-worn ‘watch’ which records all their movements throughout the day as well as their sleep patterns; participants will be asked to wear it for 24 hours a day, for 9 consecutive days. The monitor is waterproof and can be worn at all times; therefore, there should be no need for it to be removed. Participants will receive instructions on how and where to attach the monitor. All participants will be asked to do this at the start of the study then again at 4 and 12 months. The monitor cannot be used to locate anyone and does not transmit any live data while wearing it. All the movement data is stored on the watch.
What are the possible benefits and risks of participating?
It is hoped that participation in REACH-HF will improve how participants feel and how they are able to manage their heart failure. The information provided from this study will help the research team to understand how to best make home cardiac rehabilitation available for people with heart failure.
It is not expected for participants to be harmed in any way by taking part in this study. Cardiac rehabilitation for people with heart failure has been shown to be safe. As Cardiac rehabilitation involves exercise, there is always a risk that participants might initially have muscle soreness. The facilitator will make sure that the starting level of exercise is appropriate for the participant. Whilst working through some of the sections of the REACH-HF Manual with the facilitator, participants may be asked questions about their experiences with heart failure and its impact on day-to-day life which might be upsetting. The facilitators are trained health professionals and will ask questions sensitively, and participants don’t have to answer any questions which cause them to feel upset. The facilitator can refer participants to their heart failure and cardiology service or GP for further support.
Where is the study run from?
University of Glasgow (UK)
When is the study starting and how long is it expected to run for?
March 2021 to May 2026
Who is funding the study?
The study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (UK).
Who is the main contact?
The REACH-HFpEF project management team, based at the Glasgow Clinical Trials Unit can be contacted at: REACH-HFpEFproject@glasgowctu.org
Contact information
Scientific
University of Glasgow
MRC/CSO Social and Public Health Social Sciences Unit
99 Berkeley Street
Glasgow
G3 7HR
United Kingdom
 ORCID ID |
0000-0002-3043-6011 |
|---|---|
| Phone | +44 (0)141 353 7500 |
| Rod.Taylor@glasgow.ac.uk |
Public
University of Glasgow
Robertson Centre for Biostatistics
Level 11, Boyd Orr Building
University Avenue
Glasgow
G12 8QQ
United Kingdom
| Phone | +44 (0)141 330 4744 |
|---|---|
| REACH-HFpEFproject@glasgowctu.org |
Study information
| Study design | Multicentre parallel two group randomised superiority trial with nested process and health economic evaluations and internal pilot phase |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | 40192 PIS patient_v1.3 15Dec2021.pdf |
| Scientific title | Randomised controlled trial of a facilitated home-based rehabilitation intervention in patients with heart failure with preserved ejection fraction and their caregivers: The REACH-HFpEF Trial |
| Study acronym | REACH-HFpEF |
| Study objectives | Is REACH-HF plus usual care superior to usual care alone in terms of improving health-related quality of life of patients with HFpEF? |
| Ethics approval(s) |
Approved 08/09/2021, West of Scotland Research Ethics Committee 3 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 (0)141 3140213; WoSREC3@ggc.scot.nhs.uk), ref: 21-WS-0085 |
| Health condition(s) or problem(s) studied | Exercise-based cardiac rehabilitation in patients with heart failure with preserved ejection fraction (HFpEF). |
| Intervention | Randomisation will be done via the study web portal and participants will be randomly allocated in a 1:1 ratio to either intervention (REACH-HF plus usual care) or control (usual care only) groups. Usual care will be determined by local NHS policies. Randomisation will be stratified by investigator site and minimised on sex, baseline pro-brain-natriuretic peptide (NT-proBNP) levels (≤2000 vs. >2000 pg/mL), and ejection fraction (45-55% vs. >55%). The research team will be blinded to the treatment allocation. Only the rehab team will receive the allocation details. REACH-HF is a home-based cardiac rehabilitation programme providing comprehensive self-care support to the patient and their caregiver (http://sites.exeter.ac.uk/reach-hf/). This comprehensive intervention includes four core elements: 1. REACH-HF Manual for patients with a choice of two structured exercise programs: a chair-based exercise and a progressive walking training program. Patients are advised to exercise ≥3 times per week, starting from their own personal level and gradually building up over 2-3 months in time/distance/walking pace. 2. Patient ‘Progress Tracker’ – an interactive booklet designed to facilitate learning from experience to record symptoms, physical activity, and other actions related to self-care. Patient’s record: (1) how long/far they plan to walk, (2) whether they have done it, (3) how it felt to identify whether they should be moving up or down in efforts next time and (4) their weekly steps per minute (pace). 3. ‘Family and Friends Resource’ – a manual for use by caregivers aimed to increase their understanding of HF and caregiver physical and mental wellbeing. 4. Facilitation by healthcare staff (e.g., nurse, physiotherapist, exercise specialist) experienced in cardiac rehabilitation/heart failure management. Participating patients and caregivers will work through the self-help manual over a 12-week period with facilitation involving contact by a specially trained intervention facilitator (typically a cardiac rehabilitation nurse, physiotherapist or exercise specialist) who will help to assess patient needs and concerns, build the patient's and caregiver's understanding of how best to manage HFpEF and provide individually-tailored support based on each patient’s identified needs and concerns. |
| Intervention type | Behavioural |
| Primary outcome measure | Change in Minnesota Living with Heart Failure Questionnaire (MLWHF) score from baseline to 12 months. |
| Secondary outcome measures | Patients: 1. Exercise capacity measured using the Incremental Shuttle Walk Test (ISWT), performed if COVID-19 restrictions permit participants to attend clinic visits, measured at baseline, 4, and 12 months 2. Psychological wellbeing measured using Hospital Depression and Anxiety Scale (HADS) at baseline, 4, and 12 months 3. Level of physical activity measured using accelerometry (GENEActive device) at baseline, 4, and 12 months 4. Generic health-related quality of life measured using the EQ-5D-5L and Short-Form-12 at baseline, 4, and 12 months 5. Self-management measured using the Self-care of Heart Failure Index (SCHFI) & Self-efficacy for key-behaviours questionnaire at baseline, 4, and 12 months 6. Frailty measured using the Clinical Frailty Scale at baseline, 4, and 12 months 7. Prognostic biomarker measured from NT-proBNP at baseline, 4, and 12 months 8. Clinical Events measured by all-cause and heart failure-specific deaths and hospital admissions at baseline, 4, and 12 months 9. Adverse Events and Serious Adverse events recorded at baseline, 4, and 12 months Caregivers: 1. Health-related quality of life measured using EQ-5D-5L and Family Caregiver Quality of Life Scale questionnaire (FAMQoL) at baseline, 4, and 12 months 2. Psychological Wellbeing measured using Hospital Depression and Anxiety Scale (HADS) at baseline, 4, and 12 months 3. Self-management measured using Caregiver Contribution to Self-care of HF Index questionnaire (CC-SCHFI)at baseline, 4, and 12 months 4. Burden measured using Caregiver Burden for HF Questionnaire (CBQ-HF) at baseline, 4, and 12 months |
| Overall study start date | 01/03/2021 |
| Completion date | 31/05/2026 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 520 patients and their caregivers |
| Key inclusion criteria | Current participant inclusion criteria as of 03/04/2024: Patients: 1. Women or men aged ≥18 years 2. Currently symptomatic HF (NYHA Class II-IV) 3. Prescribed loop diuretics and the need for intermittent loop diuretics for the management of symptoms or signs of congestion 4. Left ventricular ejection fraction (LVEF) (within 3 years by echocardiography or MRI) ≥45% prior to randomisation. If Simpsons LVEF is missing, please use the qualitative eyeball assessment and assign a quantitative value as previously described for the BIOSTAT-CHF validation cohort [62]: 4.1. Severe: 25% 4.2. Moderate to severe: 30% 4.3. Moderate: 35% 4.4. Mild to moderate: 40% 4.5. Mild: 44% 4.6. Normal: 55% Patients defined as a ‘normal’ LVEF would therefore meet this inclusion criteria. 5. At least one of the following risk factors: 5.1. Hospital admission in last 3 years for which HF was a major contributor 5.2. N-terminal proBNP >300 pg/ml for patients with sinus rhythm in last 3 years 5.3. N-terminal proBNP >900 pg/ml for patients in atrial fibrillation in last 3 years B-type natriuretic peptide (BNP) and N-terminal prohormone B-type natriuretic peptide (NT-proBNP) levels differ in their values. Guided by the latest ESC 2021 guideline [63] values for BNP and NT-proBNP in the diagnosis of HFpEF and the conversion factor based on these values, the BNP cut offs for the REACH-HFpEF trial are as below: 5.4. 100 pg/ml (If in sinus rhythm) 5.5. 300 pg/ml (if in atrial fibrillation) 6. Informed consent to participate. Caregivers: 1. Women or men aged ≥18 years 2. Providing unpaid support to patients Cardiac rehabilitation facilitators: 1. Health care professionals facilitating and trained in the REACH-HF intervention delivery. 2. Health care professionals delivering the REACH-HF intervention to participants in the REACH-HFpEF trial. Previous participant inclusion criteria: Patient: 1. Women or men aged ≥18 years 2. Currently symptomatic HF (NYHA Class II-IV) 3. Prescribed loop diuretics and the need for intermittent loop diuretics for the management of symptoms or signs of congestion 4. Left ventricular ejection fraction (by echocardiography) ≥45% within 12 months prior to randomisation 5. At least one of the following risk factors: 5.1. Hospital admission in last 12 months for which HF was a major contributor 5.2. N-terminal proBNP >300 pg/ml for patients with sinus rhythm 5.3. N-terminal proBNP >900 pg/ml for patients in atrial fibrillation 6. Informed consent to participate Caregivers: 1. Women or men aged ≥18 years 2. Providing unpaid support to patients |
| Key exclusion criteria | Current participant exclusion criteria as of 03/04/2024: 1. Patients who have undertaken CR within the last 12 months 2. Patients who have any contraindications to exercise training (according to local cardiac rehabilitation guidelines) 3. Probable alternative diagnoses that in the opinion of the investigator could account for the patient’s HF symptoms (i.e. dyspneoa, fatigue), such as significant pulmonary disease (including primary pulmonary hypertension), anaemia, or obesity. Specifically, patients with the following should be excluded: 3.1. Severe pulmonary disease including COPD (i.e. requiring home oxygen, chronic nebulizer therapy, or chronic oral steroid therapy or hospitalised for pulmonary decompensation within 12 months) 3.2. Haemoglobin <10 g/dll 3.3. BMI >40 kg/m²; 4. Patients with prior ejection fraction <45%. 5. Patients located in a long-term care home/support setting who are considered to be too frail to engage with the intervention or who are unwilling to travel to research assessments or accommodate home visits. 6. Patients who are unable to understand the study information or unable to complete the outcome questionnaires. 7. Patients judged to be unable to participate in the study for any other reason (e.g. psychiatric disorder, diagnosis of dementia, life-threatening co-morbidity). Previous participant exclusion criteria: 1. Patients who have undertaken CR within the last 12 months 2. Patients who have any contraindications to exercise training 3. Patients who have alternative reasons for shortness of breath such as significant pulmonary disease or severe COPD, haemoglobin <10 g/dl, or body mass index (BMI) >40 kg/m² 4. Patients with prior ejection fraction <45% 5. eGFR <30 ml/min |
| Date of first enrolment | 25/05/2022 |
| Date of final enrolment | 31/05/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Department of Cardiology
Dundee
DD1 9SY
United Kingdom
84 Castle Street
Glasgow
G4 0SF
United Kingdom
University Hospital Crosshouse
Kilmarnock
KA2 0BE
United Kingdom
Lower Lane
Liverpool
L9 7AL
United Kingdom
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom
Westminster Bridge Road
London
SE1 7EH
United Kingdom
London
SE5 9RS
United Kingdom
Groby Road
Leicester
LE39 9QP
United Kingdom
Manchester University NHS Foundation Trust
Oxford Road
Manchester
M13 9WL
United Kingdom
Hardwick Road
Stockton on Tees
TS19 8PE
United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Barrack Road
Exeter
EX2 5DW
United Kingdom
Pensnett Road
Dudley
DY1 2HQ
United Kingdom
West Suffolk NHS Foundation Trust
Hardwick Lane
Bury Saint Edmunds
IP33 2QZ
United Kingdom
Derby Road
Tranmere
Wirral
Merseyside
CH42 7HA
United Kingdom
Ward 3B
Buckinghamshire Healthcare NHS Trust
Wycombe
HP11 2TT
United Kingdom
Wigginton Road
York
YO31 8HE
United Kingdom
Newport
NP20 2UB
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Innovation
Ward 11 Dykebar Hospital
Grahamston Road
Paisley
PA2 7DE
Scotland
United Kingdom
| Phone | +44 (0)141 314 4012 |
|---|---|
| Maureen.Travers@ggc.scot.nhs.uk | |
| Website | http://www.nhsggc.org.uk/ |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Current publication and dissemination plan as of 11/11/2024: Study results will be published in open-access publications in high-impact peer-reviewed journals, including an end-of-trial NIHR monograph, and will be presented at national and international conferences. The study will be featured at a stakeholder dissemination workshop (with patients, clinicians, commissioners, academics, and key groups such as the British Heart Foundation, the British Association for Cardiovascular Prevention and Rehabilitation (BACPR) and Pumping Marvellous). Direct feedback will be given to trial participants and information will be digitally publicised on the REACH-HF website and relevant profiles on social media platforms. Previous publication and dissemination plan: Planned open access publications in high-impact peer-reviewed journals including end of trial NIHR monograph. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.3 | 15/12/2021 | 13/06/2022 | No | Yes |
| Participant information sheet | version 5.0 | 19/02/2025 | 07/05/2025 | No | Yes |
| Protocol article | 27/05/2025 | 04/06/2025 | Yes | No |
Additional files
Editorial Notes
04/06/2025: Publication reference added.
07/05/2025: The following changes were made to the trial record:
1. The participant information sheet v5.0 was uploaded as an additional file.
2. The overall end date was changed from 30/11/2026 to 31/05/2026.
11/11/2024: Publication and dissemination plan updated.
03/04/2024: The following changes were made:
1. Ethics approval ref added.
2. The overall study end date was changed from 31/08/2024 to 30/11/2026.
3. The participant inclusion criteria were changed.
4. The participant exclusion criteria were changed.
5. The recruitment end date was changed from 30/11/2023 to 31/05/2025.
6. The study participating centres City Hospital, Queen Alexandra Hospital, and The Royal Wolverhampton NHS Trust were removed.
7. The study participating centres John Radcliffe Liaison Office, Cambridge University Hospitals NHS Foundation Trust and Royal Free London NHS Foundation Trust were added.
8. The intention to publish date was changed from 01/08/2025 to 01/12/2026.
16/06/2023: The recruitment end date was changed from 28/02/2023 to 30/11/2023.
13/06/2022: The following changes were made to the trial record:
1. The participant information sheet was uploaded as an additional file.
2. The ethics approval was added.
3. The trial website was added.
4. The recruitment start date was changed from 01/09/2021 to 25/05/2022.
5. The trial participating centre Royal Gwent Hospital was added.
21/07/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
